Cellectar Biosciences and City of Hope Cancer Center Enter Collaboration to Evaluate Iopofosine I 131 in Mycosis Fungoides
Cellectar Biosciences (NASDAQ: CLRB) has formed a strategic partnership with City of Hope Cancer Center to evaluate the efficacy of its lead drug, iopofosine I 131, in treating mycosis fungoides (MF), a rare form of non-Hodgkin's lymphoma (NHL). This collaboration aims to initiate trials with around 10 patients by late 2024 or early 2025. Iopofosine I 131, the first systemic targeted radiotherapeutic for cutaneous T-cell lymphomas (CTCL), may provide advantages over conventional treatments by targeting tumor cells beyond the skin. Cellectar is set to submit a New Drug Application (NDA) to the FDA in late 2024 based on its CLOVER WaM pivotal study results in Waldenstrom's macroglobulinemia (WM).
- Strategic partnership with City of Hope, a leading cancer research center.
- Iopofosine I 131 is the first systemic targeted radiotherapeutic for CTCL.
- Potential to offer significant clinical benefits for patients with MF.
- FDA Orphan Drug and Fast Track Designation for iopofosine I 131 in multiple conditions.
- Plans to submit NDA for iopofosine I 131 based on positive CLOVER WaM study results.
- Initiation of trials delayed until late 2024 or early 2025.
- The trial will evaluate only approximately 10 patients initially.
- No curable treatment options currently available for MF.
- benefit from available treatments for MF patients.
Insights
The collaboration between Cellectar Biosciences and City of Hope Cancer Center places a significant spotlight on iopofosine I 131, particularly for Mycosis Fungoides (MF). By partnering with a renowned institution, this strategic move has the potential to dramatically alter the landscape of treatment for MF and other cutaneous T-cell lymphomas (CTCL). MF currently lacks curative options and the introduction of a systemic targeted radiotherapeutic like iopofosine I 131 could provide substantial advancements.
From a clinical standpoint, this partnership is promising due to the unique mechanism of iopofosine I 131, which targets tumor cells comprehensively, potentially reducing the risk of systemic progression. Traditional external beam radiotherapy requires continuous treatments and often doesn’t address subclinical lesions and tumor stem cells effectively. If the trial yields positive outcomes, this could lead to broader applications for other CTCLs beyond MF.
In summary, this initiative marks a critical juncture for iopofosine I 131, poised to evolve MF treatment paradigms and set a precedent for future radiotherapeutics for similar conditions.
For retail investors, the announcement of this collaboration between Cellectar Biosciences and City of Hope Cancer Center deserves attention. The news impacts the company’s potential market positioning and future revenue streams. The partnership with a prestigious institution like City of Hope enhances Cellectar's credibility and increases the likelihood of successful clinical trials, which is a positive signal for potential investors.
Financially, the focus on a high unmet need in Mycosis Fungoides, a form of CTCL, opens avenues for expanded market opportunities. If iopofosine I 131 proves effective, Cellectar could see substantial revenue growth given the rarity and severity of MF, which lacks curative treatments. Furthermore, the FDA's Orphan Drug and Fast Track Designation underscores the potential expedited regulatory pathway, which may reduce time to market and associated costs.
Investors should watch for upcoming trial results and the NDA submission scheduled for the second half of 2024 as key milestones. However, it's important to remain cautious due to the inherent risks of clinical trials and regulatory approvals in the biopharmaceutical sector.
Opportunity for Iopofosine Expansion Within Areas of High Unmet Need in Non-Hodgkin’s Lymphoma
Establishes Partnership With One of the Largest Cancer Research and Treatment Organizations in the U.S.
FLORHAM PARK, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, announced today a strategic partnership with City of Hope Cancer Center, one of the largest cancer research and treatment organizations in the United States. The collaboration will focus on the clinical development of Cellectar’s lead radioconjugate asset, iopofosine I 131, in mycosis fungoides (MF), a rare form of non-Hodgkin’s lymphoma (NHL) that affects the skin and, in some patients, internal organs and blood. Iopofosine is the first systemic targeted radiotherapeutic to be assessed for cutaneous T-cell lymphomas (CTCL). The investigator sponsored trial will evaluate approximately 10 patients; initiation is planned for late 2024 or early 2025.
“We are excited to partner with Cellectar Biosciences to evaluate iopofosine in patients with mycosis fungoides,” said Dr. Steven T. Rosen, executive vice president and director emeritus, Comprehensive Cancer Center and Beckman Research Institute of City of Hope. “Its unique delivery platform targeting all tumor sites with systemic delivery may provide significant advantages over conventional external beam radiotherapy, which requires frequent and continuous therapy. Iopofosine’s demonstrated efficacy in indolent non-Hodgkins’s lymphoma may result in new treatment paradigms for these high-need patients. In addition, the ability of iopofosine to target tumor cells beyond the skin may reduce the risk of systemic progression or transformation via targeting subclinical lesions and tumor stem cells. This treatment approach may be applicable to the variety of CTCLs beyond MF.”
MF has a prevalence of approximately 30,000 patients and is the most common form of CTCL. It is a slow-growing form of blood cancer in which some of the body's white blood cells become malignant and has no curable treatment options. The most common presentation is skin rash, plaques and tumors on the skin resulting in disfigurement, severe and debilitating pruritis, and in some cases involves blood and internal organs that may lead to death.
“City of Hope is a world-renowned cancer research center with extensive clinical expertise and Dr. Steven Rosen is a recognized global leader in oncology research, development and clinical care,” said Dr. Andrei Shustov, Cellectar’s senior vice president, medical. “This collaboration further substantiates iopofosine as a potential treatment for a wide variety of cancers. Iopofosine’s unique qualities may translate into significant clinical benefit and change the MF treatment paradigm for patients with no available curative options and limited benefit from available treatments.”
The U.S. Food and Drug Administration (FDA) has granted iopofosine I 131, a small-molecule Phospholipid Drug Conjugate™ (PDC) designed to provide targeted delivery of iodine-131 (radioisotope), Orphan Drug and Fast Track Designation for relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM), r/r multiple myeloma and r/r diffuse large B-cell lymphoma (DLBCL).
Cellectar is preparing to submit a New Drug Application (NDA) to the FDA based on its CLOVER WaM pivotal study in WM in the second half of 2024. The company previously announced topline data from its CLOVER WaM pivotal study earlier this year and plans to announce updated results in June.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.
About City of Hope
City of Hope was founded in 1913 and has grown into one of the largest cancer research and treatment organizations in the U.S. City of Hope research has been the basis for numerous breakthrough cancer medicines. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations regarding the CLOVER WaM pivotal trial. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2023, and our Form 10-Q for the quarter ended March 31, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
Contacts
MEDIA:
Claire LaCagnina
Bliss Bio Health
315-765-1462
clacagnina@blissbiohealth.com
INVESTORS:
Chad Kolean
Chief Financial Officer
investors@cellectar.com
FAQ
What is the focus of Cellectar's recent partnership with City of Hope?
When will the trial for iopofosine I 131 in mycosis fungoides start?
What distinguishes iopofosine I 131 from other treatments for mycosis fungoides?
What designations has iopofosine I 131 received from the FDA?
When will Cellectar submit the New Drug Application (NDA) for iopofosine I 131?
